M7(R2) Addendum: Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes

On 6 April 2022 the FDA published draft guidance on ICH M7 addendum for industry.

The ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug development and manufacturing and the products available to patients.

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